In recent years, as consumer interest in Well-being and natural foods has increased, the use of natural additives in place of synthetic additives in the food industry has gradually increased, and the range of application thereof also has continued to increase.
In particular, in pharmaceutical drugs and health functional foods, safety and environmentally friendly factors in production processes are considered important, and thus many products containing natural components are being developed and the market size thereof is also increasing.
In the pharmaceutical and food industries, various excipients are used to prepare internal solid dosage forms. These excipients are widely involved in the flow properties of mixtures, compression properties in tablet preparation, disintegration properties for smooth disintegration, sticking properties in which powder sticks to the surface of tablet compression punches to cause defects on the tablet surface, capping in which the upper portion of tablets is peeled off in a cap shape during compression, lamination in which a tablet is peeled off in a layered fashion, and binding properties for enhancing the hardness of tablets.
Generally, pharmaceutical drug products are mostly produced by a wet granulation process in which a solution is added to powders for granulation. In the wet granulation process, when granules are over-dried, a large amount of fine powder occurs during the tableting of the over-dried granules and this fine powder has poor flowability in a tablet compression machine, and thus causes a variation in the weight of tablets and results in capping and lamination. For this reason, non-natural synthetic additives such as a binder (hydroxypropylmethylcellulose, corn starch etc.) are used for the granulation of such powder.
If active ingredients are sensitive to water or heat, dry granulation processes are sometimes used, and a roller compactor is widely used as one of dry granulation processes which are generally used. Most of the dry granulation processes do not use moisture, and thus do not cause problems of picking and sticking in which uneven spots occur on the surface of tablets.
Direct compression is a method of making complete tablets by mixing each components and compressing the mixture into tablets without changing any component.
Despite many efforts to substitute natural additives for synthetic additives, synthetic additives for formulation are inevitably being used in tablet products, which are widely used in the pharmaceutical and health functional food industries, due to various problems occurring during processes, including sticking which a disc (a plate with which a mixture for compression comes into contact) sticks to a surface of punch in a tablet compression machine.
Among these synthetic additives, stearic acid or magnesium stearate which is most widely used as a lubricant shows excellent lubricant performance even when it is used in an amount of 0.5-1 wt % based on the total weight of a mixture for compression, and also assists in improving the flowability of the mixture. Also, if the flowability of a pharmacological mixture needs to be improved, a glidant such as silicon dioxide or talc is widely used. However, the above materials are all chemical synthetic products which significantly interfere with the development of formulations comprising only natural components.